MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER PORT ISP M.R.I., 8FR GROSHONG; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 4808570J

Device Problems Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided and a lot history review will be performed.The return of the sample is pending.The company is still investigating the issue at this time.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that the model 4808570j port & catheter, implanted, subcutaneous, intravascular allegedly experienced foreign material that looked like hair.This information was received from one source.This malfunction did not involve a patient as there was no patient contact.The patient's age, sex and weight were unknown.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that the model 4808570j port & catheter, implanted, subcutaneous, intravascular allegedly experienced foreign material that looked like hair.This information was received from one source.This malfunction did not involve a patient as there was no patient contact.The patient's age, sex and weight were unknown.

Manufacturer Narrative

H10: as the lot number for the devices was not provided, a lot history review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: POWER PORT ISP M.R.I., 8FR GROSHONG
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10752950
• MDR Text Key: 214805393
• Report Number: 3006260740-2020-03570
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 4808570J
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 12/31/2020
• Supplement Dates FDA Received: 01/07/2021
• Patient Sequence Number: 1